CClinicalTrials.gg
Sign In
TerminatedNCT05252390Updated Nov 6, 2025

NUV-868 as Monotherapy and in Combination With Olaparib or Enzalutamide in Adult Patients With Advanced Solid Tumors

A Phase 1 interventional study of NUV-868 and Olaparib in Advanced Solid Tumor, Ovarian Cancer and Ovary Cancer, sponsored by Nuvation Bio Inc.. Terminated at 22 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-06.

Sponsored by Nuvation Bio Inc. · Phase 1, Interventional, and Treatment

Why this study was terminated
The Sponsor has achieved its objectives.

From the registry’s dates

  • Primary completion was Jul 2024, 2 years 2 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
82
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

NUV-868-01 is a first-in human, open- label, Phase 1/2 dose escalation and expansion study in patients with advanced solid tumors. The Phase 1 and 1b portions include patients with advanced solid tumors and are designed to determine the safety and the dose(s) of NUV-868 to be used as monotherapy and in combination with olaparib or enzalutamide for the Phase 2 portion. In Phase 2, NUV-868 in combination with olaparib or enzalutamide will be given to determine the safety and efficacy of these study treatments. One cohort of patients (with enzalutamide-naïve metastatic castration-resistant prostate cancer) will be randomized to receive either NUV-868 monotherapy, enzalutamide monotherapy, or the combination of NUV-868 + enzalutamide. Patients will self-administer NUV-868 orally daily in 28-day cycles as monotherapy in Phases 1 and 2. In Phases 1b and 2, patients will self-administer NUV-868 orally daily in 28-day cycles in combination with olaparib or enzalutamide daily at standard prescribed doses (Phase 1b) or at the recommended Phase 2 combination dose (RP2cD) that is determined in Phase 1b. Patients will be treated until disease progression, toxicity, withdrawal of consent, or termination of the study.

Read the detailed description

This study was initially planned as a Phase 1/2 study; however, the study stopped early prior to the start of Phase 2.

02

Conditions studied

  • Advanced Solid Tumor
  • Ovarian Cancer
  • Ovary Cancer
  • Cancer of Ovary
  • Cancer of the Ovary
  • Ovary Neoplasm
  • Pancreatic Cancer
  • Pancreas Cancer
  • Cancer of Pancreas
  • Cancer of the Pancreas
  • Pancreas Neoplasm
  • Prostate Cancer
  • Prostatic Cancer
  • Cancer of Prostate
  • Cancer of the Prostate
  • Prostate Neoplasm
  • Castrate Resistant Prostate Cancer
  • Castration Resistant Prostatic Cancer
  • Castration Resistant Prostatic Neoplasms
  • Triple-negative Breast Cancer
  • Triple Negative Breast Cancer
  • Triple Negative Breast Neoplasms
  • Breast Cancer
  • Breast Carcinoma
  • Cancer of Breast
  • Cancer of the Breast
  • Breast Tumor

Keywords

  • Phase 1
  • Phase 2
  • NUV-868
  • olaparib
  • enzalutamide
  • Xtandi
  • ovarian cancer
  • pancreatic cancer
  • metastatic castration-resistant prostate cancer
  • triple-negative breast cancer
  • Lynparza
  • PARP inhibitor
  • BET inhibitor
  • BRCA mutation
  • BRCA1
  • BRCA2
  • HRD
  • HRR deficiency
  • homologous recombination deficiency
03

In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's enrollment of 82 is above the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Nuvation Bio Inc. is the lead sponsor of 19 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria For All Phases and Cohorts:

  1. Recovered from toxicity to prior anticancer therapy
  2. Adequate bone marrow and organ function
  3. No known active or symptomatic central nervous system (CNS) disease

Cohort-Specific Inclusion Criteria: In addition to the inclusion criteria listed above, the following criteria apply for enrollment into specific cohorts.

Phase 1 (NUV-868 Monotherapy)

  1. Patients with advanced solid tumors that have progressed during or after treatment with approved therapies or for which there is no standard effective therapy available
  2. Life expectancy of > 3 months
  3. Eastern Cooperative Oncology Group Performance Status ≤ 2
  4. Measurable or non-measurable disease

Phase 1b (NUV-868 in Combination With Enzalutamide or Olaparib)

  1. Life expectancy of > 3 months
  2. Eastern Cooperative Oncology Group Performance Status ≤ 2
  3. (Select cohorts only) Measurable disease
  4. Patient must be able to read and write sufficiently to document food intake and study drug dosing on the Dosing Diary or must have a caregiver who is willing and able to complete the Dosing Diary with the patient.

  5. One of the following tumor types:

    1. Ovarian: Platinum-resistant OR platinum-refractory high grade serous ovarian, fallopian, or primary peritoneal cancer in the relapsed setting
    2. Pancreatic: Pancreatic ductal adenocarcinoma (PDAC) with progression on or after treatment with at least one line of systemic chemotherapy in the advanced setting
    3. Prostate: Histologically confirmed, metastatic adenocarcinoma of the prostate (adenocarcinoma/high grade carcinoma with neuroendocrine features is allowed) with progression on or after treatment with at least one NHT in the metastatic setting
    4. Breast: Triple-negative breast cancer (TNBC) with progression on or after treatment with at least one line of systemic chemotherapy in the advanced setting
    5. Other advanced tumors (only Phase 1b dose escalation, NUV-868 + olaparib): the study Medical Monitor must approve enrollment.
    6. For all tumor types: Patients will be allowed in the study regardless of their BRCA/HRR status.

Phase 2

  1. Life expectancy of > 6 months
  2. (Select cohorts only): At least one measurable lesion defined by standard criteria
  3. Eastern Cooperative Oncology Group Performance Status ≤ 1

  4. One of the following tumor types:

    1. Ovarian: Platinum-resistant or platinum- refractory high grade serous ovarian, fallopian, or primary peritoneal cancer in the relapsed setting
    2. Pancreatic: Progression on or after treatment with at least one line of systemic chemotherapy in the advanced setting
    3. Prostate: Histologically confirmed, metastatic adenocarcinoma of the prostate (adenocarcinoma/high grade carcinoma with neuroendocrine features is allowed) with progression on or after treatment with at least one NHT in the metastatic setting
    4. Breast: TNBC with progression on or after treatment with at least one line of systemic chemotherapy in the advanced setting

Key Exclusion Criteria For All Phases and Cohorts:

  1. Have received chemotherapy, hormonal therapy (except for ongoing luteinizing hormone-releasing hormone [LHRH] analogs in male patients and premenopausal women), radiation, or biological anticancer therapy within 14 days prior to the first dose of NUV-868.
  2. Received treatment with an investigational agent for any indication within 14 days for non-myelosuppressive agent, or within 21 days or \< 5 half-lives (whichever is longer) for myelosuppressive agent, prior to the first dose of study treatment.
  3. Requires medications that are known to be strong (or moderate for olaparib) inducers and/or strong (or moderate for olaparib) inhibitors of CYP3A4/5 enzymes.
  4. Female patients who are pregnant of breastfeeding.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
82 participants (actual)

Study arms

  • Experimental
    Phase 1 Monotherapy

    NUV-868 will be administered at escalating dose levels until the maximum tolerated dose (MTD) is reached or a recommended Phase 2 dose (RP2D) is determined.

    Drug: NUV-868

  • Experimental
    Phase 1b Combination: NUV-868 + Olaparib

    NUV-868 will be administered at escalating dose levels in combination with olaparib until the recommended Phase 2 combination dose (RP2cD) is determined. 300 mg olaparib will be administered orally twice daily throughout the 28-day cycles of NUV-868.

    Drug: NUV-868 · Drug: Olaparib

  • Experimental
    Phase 1b Combination: NUV-868 + Enzalutamide

    NUV-868 will be administered daily at escalating dose levels in combination with enzalutamide until the RP2cD is determined. 160 mg enzalutamide will be administered orally daily throughout the 28-day cycles of NUV-868.

    Drug: NUV-868 · Drug: Enzalutamide

  • Experimental
    Phase 2 Combination: NUV-868 + Olaparib

    NUV-868 will be administered at the RP2cD. Olaparib will be administered at the RP2cD.

    Drug: NUV-868 · Drug: Olaparib

  • Experimental
    Phase 2 Combination: NUV-868 + Enzalutamide

    NUV-868 will be administered at the RP2cD. Enzalutamide will be administered at the RP2cD.

    Drug: NUV-868 · Drug: Enzalutamide

  • Experimental
    Phase 2: NUV-868 Monotherapy

    NUV-868 will be administered at the RP2D in one arm of a randomized Phase 2 combination (NUV-868 + enzalutamide) cohort.

    Drug: NUV-868

  • Active comparator
    Phase 2: Enzalutamide Monotherapy

    160 mg enzalutamide will be administered orally daily in one arm of a randomized Phase 2 combination (NUV-868 + enzalutamide) cohort.

    Drug: Enzalutamide

Interventions

  • DrugNUV-868

    NUV-868 is an investigational drug for oral dosing.

  • DrugOlaparib

    Olaparib

    Also known as: Lynparza

  • DrugEnzalutamide

    Enzalutamide

    Also known as: Xtandi

06

What researchers measure

Primary outcomes

  1. Phase 1 Monotherapy Dose Escalation: Safety and tolerability of NUV-868 to determine the recommended Phase 2 dose (RP2D)

    Incidence of dose-limiting toxicities (DLTs)

    Time frame: During the DLT period (28 days)

  2. Phase 1b Dose Escalation, NUV-868 + Olaparib: Safety and tolerability of NUV-868 in combination with olaparib to determine the recommended Phase 2 combination dose (RP2cD)

    Incidence of DLTs

    Time frame: During the DLT period (28 days)

  3. Phase 1b Dose Escalation, NUV-868 + Olaparib: Pharmacokinetic (PK) profiles of NUV-868 and olaparib when administered in combination

    NUV-868 and olaparib combination PK

    Time frame: Days 1, 8, and 29

  4. Phase 1b Dose Escalation, NUV-868 + Enzalutamide: Safety and tolerability of NUV-868 in combination with enzalutamide to determine the RP2cD

    Incidence of DLTs

    Time frame: During the DLT period (28 days)

  5. Phase 1b Dose Escalation, NUV-868 + Enzalutamide: Pharmacokinetic (PK) profiles of NUV-868 and enzalutamide when administered in combination

    NUV-868 and enzalutamide combination PK

    Time frame: Days 1, 8, and 57

  6. Phase 2, NUV-868 + Olaparib: Change from Baseline in Tumor Imaging

    ORR per standard criteria

    Time frame: Every 8 weeks during the first 24 weeks and then every 12 weeks, up to an average of 12 months (end of treatment)

  7. Phase 2, NUV-868 + Olaparib: Change from Baseline in PSA measurements

    PSA50 response rate per standard criteria; only for patients with prostate cancer

    Time frame: Every 4 weeks throughout study treatment, up to an average of 12 months (end of treatment)

  8. Phase 2, NUV-868 + Enzalutamide in Enzalutamide-Naïve Metastatic Castrate-Resistant Prostate Cancer (mCRPC): Time from First Dose to Disease Progression

    Radiographic progression-free survival (rPFS) per standard criteria

    Time frame: Every 8 weeks during the first 24 weeks and then every 12 weeks, up to an average of 12 months (end of treatment)

  9. Phase 2, NUV-868 + Enzalutamide in Enzalutamide-Resistant mCRPC: Response to Study Treatment

    Composite response rate (CRR: radiologic response, PSA50 response, and/or circulating tumor cell response) per standard criteria

    Time frame: Every 4-12 weeks (time points vary depending on the type of response being evaluated) throughout study treatment, up to an average of 12 months (end of treatment)

  10. Phase 1b Food Effect Substudy: Effect of Food on the Pharmacokinetics (PK) of NUV-868

    NUV-868 PK parameters in fed and fasted states

    Time frame: Pre dose and 24 hours after the first and second doses of NUV-868, 7 days apart

07

Study locations

22 sites
  • The University of Arizona Cancer Center
    Tucson, Arizona 85724, United States
  • Ellison Institute of Technology
    Los Angeles, California 90064, United States
  • Rocky Mountain Cancer Centers, LLP
    Aurora, Colorado 80012, United States
  • Rocky Mountain Cancer Centers, LLP
    Lone Tree, Colorado 80124, United States
  • H. Lee Moffitt Cancer Center
    Tampa, Florida 33612, United States
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    Baltimore, Maryland 21231, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Karmanos Cancer Institute
    Detroit, Michigan 48201, United States
  • Laura & Isaac Perlmutter Cancer Center - NYU Langone Health
    New York, New York 10016, United States
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
  • Carolina BioOncology Institute
    Huntersville, North Carolina 28078, United States
  • Fox Chase Cancer Center
    Philadelphia, Pennsylvania 19104, United States
  • Sarah Cannon Research Institute - Tennessee Oncology
    Nashville, Tennessee 37203, United States
  • Mary Crowley Cancer Research
    Dallas, Texas 75230, United States
  • Texas Oncology - Fort Worth Cancer Center
    Fort Worth, Texas 76104, United States
  • NEXT Virginia
    Fairfax, Virginia 22031, United States
  • Virginia Oncology Associates
    Norfolk, Virginia 23502, United States
  • Macquarie University Hospital
    North Ryde, New South Wales 2109, Australia
  • Calvary Mater Hospital Newcastle
    Waratah, New South Wales 2298, Australia
  • Cabrini Hospital Malvern
    Malvern, Victoria 3144, Australia
  • Peter Maccallum Cancer Centre
    Melbourne, Victoria 3000, Australia
  • Linear Clinical Research
    Nedlands, Western Australia 6009, Australia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05252390
Lead sponsor
Nuvation Bio Inc.
Responsible party
Sponsor
First posted
Feb 23, 2022
Start date
Mar 29, 2022
Primary completion
Jul 15, 2024
Completion
Jul 15, 2024
Last update
Nov 6, 2025

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Ovarian Neoplasms→

Other studies from this sponsor

Nuvation Bio Inc.

Start the discussion